1. Field of the Invention
This invention relates to pharmaceutical compositions for application to the skin and to a method for the treatment of proliferating skin diseases. The composition may be applied topically. The treatment can be either therapeutic or prophylactic.
2. Description of Related Art
Proliferative skin diseases are widespread throughout the world and afflict millions of humans and their domesticated animals. This invention provides a method for treatment of such diseases. As used hereinafter in this specification and in the claims, the expression “proliferative skin diseases” means benign and malignant proliferative skin diseases which are characterized by accelerated cell division in the epidermis, dermis or appendages thereto, associated with incomplete tissue differentiation. Such diseases include: psoriasis, atopic dermatitis, non-specific dermatitis, primary irritant contact dermatitis, allergic contact dermatitis, basal and squamous cell carcinomas of the skin, lamellar ichthyosis, epidermolytic hyperkeratosis, premalignant sun-induced keratosis, non-malignant keratosis, acne, and seborrhic dermatitis in humans and atopic dermatitis in domesticated animals.
Heretofore, proliferative skin diseases have been generally accepted by mankind as an ongoing evil having degrees of severity variable with inherited skin traits and external factors but always have been recognized as unsightly, painful, morbid diseases. Over the history of mankind innumerable medicines and treatments have been proposed, tried and used with varying degrees of success.
Treatments which are prescribed and used for the treatment of proliferative skin diseases include the following:
(1) topical applications, e.g. coal tar derivatives, 5-fluorouracil, vitamin A acid, glucocorticoids in high dosage, bath oils and non-specific emollient creams and ointments;
(2) systemic administration, e.g. glucocorticoids and classic anti-cancer agents, for example, methothrexate, hydroxyurea, azaribine, cyclophosphamide; and
(3) physical modalities, e.g. ultra violet light, x-radiation, and, in severe cases, surgery.
While these treatments provide, in certain cases some remission of the original symptoms, each treatment suffers some defect, for example, temporary and incomplete mitigation of symptoms, rapid re-occurrence of the disease when mitigation is terminated, serious and sometimes irreversible damage (atrophy) resulting from the topical application for extended times of glucocorticoids, acute bone marrow suppression, cirrhosis of the liver resulting from the protracted use of methothrexate which may lead to death of the patient, and the causation of cancer by the application of anti-cancer drugs, x-radiation, or ultra violet rays.
Recently, a new compound has been approved by the Food and Drug Administration for the treatment of psoriasis and acne. Tazarotene. Tazarotene is available as Tazorac® 0.1% and Tazorac® 0.05% topical gel from Allergan, Inc. of Irvine, Calif.